The iMc Institute: An example for practice-based research

08.04.2019

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The truth is that as clinicians we are all practice-based researchers. When we diagnose our patients, choose treatments and follow results, we are really performing research, whether we know it or not.

Dr. Michael K. McGuire | United States

Our research questions are endless. We have many diagnostic tools, like patient medical and dental histories, probing measures, periapical radiographs and CBCT scans; but we should continually be asking ourselves which diagnostics are appropriate and how they should best be used to form treatment options.

Should we use antibiotics, and if so, what type and dosage? Which incision and flap techniques are best? What biomaterials are most successful, and what post-operative care is most beneficial?

In reality our diagnoses, prognoses and treatment plans are our "study hypotheses and methods," and our patient outcomes are our "study results." No matter what we learned in dental school or through continuing education, the longer we practice the more we get to observe our clinical results, perhaps comparing with other clinicians or the literature, so that we arrive at what we believe are our best practice "study conclusions." But the validity of our conclusions needs to be tested, continually, because as medical techniques and technologies evolve, there are more alternatives we should also be "studying." Therein lies our role in continuing, practice-based research. The only question is whether we want to formally plan, record and publish our "research results."

The first steps

My own path toward practice-based research started in the 1970s. Early in my career I desperately wanted to contribute to the literature, and as a young practitioner I did not know how to get grants and was certainly not going to find a company willing to support my research. So, I looked for a project that I could do in my own practice. There was some classic literature (Hirschfield, Wasserman, McFall and others) retrospectively evaluating patient populations, and I remember reading a paper about patient maintenance and thinking, "Gee, I could have done that!"

So, one day after giving a lecture to the residents in San Antonio, I began thinking about prognosis and what we really knew about it. I retrospectively analyzed 100 of my patients, examining whether the prognoses (and associated treatments) I had assigned were predictive of outcomes 5- and 10-years later. I was the sole author, and it was the first time I had ever attempted to publish anything, so I did not really understand the publication process (manuscript organization, submission and review). I submitted my work to the Journal of Periodontology, and it was rejected, without reviewer comments.

While I was very disappointed, I thought I had no recourse, until Dr. Raul Caffesse, who knew that I had been writing the paper, asked me about it. After I told Dr. Caffesse my experience, he contacted the journal editor and asked him to "give the kid a chance." I eventually received the reviewers' comments and was able to make corrections that satisfied the journal. Ultimately the paper was published, and it is interesting that this paper is one of the publications I am now known for around the world.1 It's now considered classic literature.

The achievement

Now I find myself leading a network of 16 practice-based investigators - Periodontists and Oral Maxillofacial Surgeons, and more recently general dentist sub-investigators helping us with restorative research. We have practices across the United States, and we are like-minded. We all want to use research to understand how best to treat our patients, and we appreciate the value of practice-based research, where real patients are treated in real practices. (We also appreciate and collaborate with universities, where particular types of research - for example, inflammatory biomarker diagnostics, gene therapy development and government grant projects - are best developed and studied.)

Our investigators have published more than 350 peer-reviewed papers, and every year they provide an average of 70 regional, 45 national and 15 international lectures. They are active at all levels of organized dentistry and are editors or on the editorial boards of respected, peer-reviewed journals. We all believe in the power of practice-based research and think it provides more rapid translation of new therapies into clinical practice.2

The McGuire Institute - A Practice-based Clinical Research Network

What it will take

Decide whether you really want to be a practice-based researcher. Consider that you might make less money and actually work harder and longer than you would if you simply treated patients in your practice. You will be creating study protocols, looking for grants or industry sponsors, filling out clinical reporting forms (CRFs), analyzing results, writing study manuscripts and shepherding them through journal review processes. If you have a practice partner, it helps if they support your work, and it's even better if they collaborate with you. I am very grateful my partner Dr. E. Todd Scheyer not only supports practice-based research but also has been a collaborating investigator and author, while supporting the founding of The McGuire Institute (iMc).

I think the biggest challenge is incorporating high quality clinical research into a busy private practice. In order to do that, it takes the development of systems and staff so that you can function smoothly and not disrupt your practice. You will need dedicated office staff to recruit patients, coordinate study progress and help record and report results. I would be nowhere without the excellent hygienists, surgical assistants and our Study Coordinator who, as a team, make sure our research works!

I created iMc primarily as a legacy project. After I give lectures, especially at big periodontology meetings, someone often comes up to me and says, "Hey, that's cool. I would like to do that. Tell me how you do it." Through iMc we are able to help clinicians learn how to run high-level studies in an efficient way that benefits them, the profession and their patients.

Help, tools and references

Find research mentors. You have read (above) how Dr. Caffesse and others helped me. But the opportunity that really got me started was a study organized by Drs. Ken Kornman and Mike Newman for a local delivery, tetracycline-impregnated cord for periodontitis. To my knowledge this was one of the first, large, practice-based clinical research studies done in dentistry.3 Ken, Mike and their team helped train one of our hygienists and me in the basics of practice-based research, and it was "love at first study."

Find expert study collaborators and partners. Dr. Newman taught me about evidence-based dentistry (and was the founding editor of the Journal of Evidence-Based Dental Practice). Biostatistician Dr. Jack Gunsolley calibrates our examiners (so we can measure our study results consistently and accurately across the country), creates the statistical designs that power our studies and statistically analyzes our results. Researcher Dr. Thiago Morelli, University of North Carolina, recently introduced us to a new, super-accurate, 3-D digital intraoral scanning technique for measuring oral soft tissue changes within 0.05 mm accuracy. Dr. Alan Herford (Loma Linda University) has helped us with histological analyses. Dr. Will Giannobile, the University of Michigan, the University of Pittsburg and the Harvard/ Wyss Institute have partnered with iMc under an NIDCR tissue engineering and regenerative medicine research grant. In this very competitive process, new technologies are selected to receive funding, and iMc has been chosen to help select and shepherd these new therapies through pre-clinical studies and into human clinical trials. In addition, our patient reported outcomes "PROs pro," sociologist Chad Gwaltney, PhD (Brown University), helps interview patients who undergo, for example, laser procedures, and then creates the PROs questions and questionnaires that tell us about pain, anxiety and what therapies patients really prefer.

iMc has also partnered with the clinical research organization Medelis, Inc., which helps us organize, initiate and monitor our multi-center studies. Regularly we gather with Medelis for good clinical practice (GCP) training. GCP guidance for the US can be found within the Food and Drug Administration's Code of Federal Regulations (21 CFR), and there is a similar guidance for European studies. This year many of our study coordinators and examiners traveled to Houston and Phoenix for calibration and GCP training in preparation for our ongoing laser and Geistlich Fibro-Gide® studies.

Besides 21 CFR, there are other helpful guides and references, like the Osteology Guidelines for Oral and Maxillofacial Regeneration - Clinical Research.4 This useful book includes advice and tools for designing and conducting clinical studies. There are also "how-to" guides for writing manuscripts, like Dodson's A guide for preparing a patient-oriented research manuscript,5 or conducting PROs.6,7 All the help you need is out there. It just takes a bit of effort (and some late night reading) to get it.

Rewards

The rewards? I'm very grateful for where my career and my research have taken me. Practice-based research has certainly made my practice more interesting, and it has allowed me access to technologies and devices that I would not have experienced otherwise. Dr. Scheyer and I have been able to offer some of the newest treatment options for our patients. Research has also set our practice apart from others and often provided our patients with free therapy or therapy at a reduced cost. Clearly, we have enjoyed the notoriety research brings, and I have enjoyed the travel and the camaraderie my speaking engagements have provided. In the end, it's all about job satisfaction. If you enjoy dentistry and you enjoy research, and what both can do for your patients, you too might want to consider practice-based research.